Galcanezumab Effective at Decreasing Monthly Headache Days in Migraine
Galcanezumab is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide.
Galcanezumab has demonstrated efficacy in treating episodic migraine, with 40% of users achieving a 100% response rate for at least 1 month, according to a study recently published in Headache.
This study included 1739 individuals with episodic migraine, 436 of whom were randomly assigned galcanezumab 120 mg, 428 of whom were randomly assigned galcanezumab 240 mg, and 875 of whom were randomly assigned placebo. Those given galcanezumab 240 mg showed the highest mean monthly 100% response rate (14.3%; odds ratio 2.6; P <.001), followed by galcanezumab 120 mg (13.5%; odds ratio 2.5; P <.001) and placebo (5.9%).
Over the 6-month, double-blind segment of the study, the mean monthly 100% response rate rose from 9% to 21% in the galcanezumab groups vs 2% to 10% in the placebo group (P <.02). Either dose group was more likely to have achieved a 100% response than placebo (P <.001 for ≤3 months), although those on galcanezumab rarely showed 4 or more months of total response (P <.02).
The final 3 months of treatment showed the highest levels of 100% response. The length of headache-free periods among galcanezumab users with ≥1 month of total response was 29 days, while for those with ≥3 months of total response, it was 55 days. By comparison, the baseline mean gap between headaches was 5 days.
Both studies included in this post hoc analysis were double-blind and included individuals with at least 2 migraines each month and between 4 and 14 monthly headache days at baseline. To find the mean monthly response rate, a generalized linear mixed model was used. To assess statistical significance, 2-sided tests with P≤.05 were used.
The study researchers conclude that “[around] 40% of the patients with episodic migraine treated with galcanezumab achieved 100% response for at least 1 month. The percentages of patients with 100% response increased by month in the 6-month double-blind period; very few patients (0.7 to 1.4%) achieved 100% response for all 6 months of the study. More patients had 100% monthly response in the last 3 months. For those with at least 1 month of 100% response, the average time between non-consecutive [migraine headache days] for the entire treatment period was nearly 1 month and approached 2 months for patients with 3 or more months of 100% response.”
This study was funded by Eli Lilly and Company, and authors report multiple associations with pharmaceutical companies. Please see reference for full list of author disclosures.
Rosen N, Pearlman E, Ruff D, Day K, Nagy AJ. 100% response rate to galcanezumab in patients with episodic migraine: a post hoc analysis of the results from phase 3, randomized, double-blind, placebo-controlled EVOLVE-1 and EVOLVE-2 studies[published online October 20, 2018]. Headache. doi: 10.1111/head.13427